Spinal orthosis, kit and method for using the same

ABSTRACT

A spinal orthosis includes a rear panel, and first and second belt members securing to the rear panel. The first and second belt members each define a first end secured to a first side of the rear panel and a second end having a foldable portion adapted to fold over a first surface of the first and second belt members and secure to the first surface to reduce a length of the first and second belt members. First and second front closures are secured to the second ends of the first and second belt members, respectively, and arranged for removably securing to one another to form a continuously circumferential loop with the rear panel and the first and second belt members. A kit or method may be provided for sizing the belt members with a sizing device for forming a predetermined distance between the first and second belt members.

FIELD OF THE DISCLOSURE

The disclosure relates generally to orthopedic devices, and morespecifically to a spinal orthosis.

BACKGROUND

A spinal orthosis or lumbar support is an orthopedic device designed forpain relief, protecting injured ligaments or muscles and post-surgicalimmobilization. A spinal orthosis is arranged to relieve pressure overthe spinous processes while applying an even pressure to the paraspinalmusculature to ensure comfortable and effective healing. Typicalindications for spinal orthoses include spinal stenosis, herniateddiscs, post-surgical stabilization, stable and non-displaced spinalfractures, spondylolithesis, spondylolysis, and degenerative spinalpathologies.

In a known spinal orthosis in FIGS. 1-3, such as the exemplary spinalorthosis described in U.S. Pat. No. 8,172,779, granted on May 8, 2012and incorporated by reference, the spinal orthosis has outer and innerside configurations 10A, 10B, with the inner side arranged to beadjacent the user's back. The orthosis has first and second belt members12, 14, and a compression or closure system 16 adapted to exert pressureonto the lumbar region of a user's back. The compression or closuresystem 16 includes tightening elements or drawstrings 18 that permit theuser to adjust pressure over the back and a cover 20 extending over thecompression system 16.

A flexible or semi-rigid back plate 22 extends over at least part of thecompression system 16, and is arranged to be adjacent the back of theuser. The back plate 22 includes a posterior attachment system 24 for arigid posterior panel 26, including a single hook and loop systemconnected at a single attachment point or flap 25 centered on the backplate 22. An anterior panel may be attached to the spinal orthosis at ananterior attachment system on one of the belts.

A requirement in a spinal orthosis is that they immobilize, at least inpart, the torso, and stabilize the back. A factor in achieving thisrequirement is that the spinal orthosis is properly sized according tothe anatomy of the user, and allows the user to effectively position andfasten the spinal orthosis.

It is desired to provide only a few spinal orthosis sizes. There is aneed for a spinal orthosis that permits resizing of belt lengths tooffer a “one-size-fits-all” spinal orthosis, including means, ifnecessary, to facilitate resizing of the spinal orthosis as a userundergoes size changes during rehabilitation.

SUMMARY

According to the embodiments described herein, a spinal orthosis isarranged for creating circumferential compression for a user,particularly in the lumbar region of the spine. The spinal orthosisenables saggital and/or coronal control, while offering a superiorlycomfortable spinal orthosis. Indications for the spinal orthosis mayinclude spinal stenosis, herniated disc, and degenerative spinalpathologies. The spinal orthosis may be combined with rigid panels forpost-surgical stabilization; stable, non-displaced spinal fractures;spondylolisthesis; spondylolysis; spinal stenosis; herniated disc; anddegenerative spinal pathologies.

Various embodiments are arranged with significant improvement over knownspinal orthoses in donning and fitting processes. The donning andfitting processes may be made without measurements, and catered toanatomy and changing anatomy of a given user. The donning and fitting isarranged so it can be done on the actual user and thereby particularlycustomized for optimal fit and performance. No trimming is required fordonning and fitting to a user, and no complicated fasteners or bucklesare required for donning and fitting to a user. The length of the beltmembers can be increased, such as with belt extenders, or reduced, byfolding, from an initial length, and such initial length can always bepreserved for further adjustment of an actual length (such as includingbelt extenders or being folded and attached) of the belt member in thecontext of wearing the belt members.

The embodiments are arranged with flexible and breathable materialshaving improved performance over known spinal orthosis, includingventilation features offering optimal breathability in strategiclocations. The spinal orthosis is arranged to accommodate many sizes byhaving means for expanding belt member lengths. The embodiments possessstreamlined features which reduce weight, size and bulk over knownspinal orthoses.

According to an embodiment of a spinal orthosis, the spinal orthosisincludes a rear panel having first and second sides, and first andsecond belt members securing to the rear panel. The first belt memberdefines a first end secured to a first side of the rear panel and asecond end having a foldable portion adapted to fold over a firstsurface of the first belt member and secure to the first surface toreduce a length of the first belt member. The second belt member has afirst end secured to a second side of the rear panel and a second endhaving a foldable portion adapted to fold over a first surface of thesecond belt member and secure to the first surface to reduce a length ofthe second belt member. First and second front closures are securable tothe second ends of the first and second belt members, respectively, andarranged for removably securing to one another to form a continuouslycircumferential loop with the rear panel and the first and second beltmembers.

The first front closure may include a locking element defined on a firstside and arranged to engage a corresponding slot defined on a first sideby the second front closure for securing the first and second beltmembers to one another. The first front closure defines a pocket along afirst side, and configured and dimensioned for inserting at least afinger thereinto for locating a second end of the first front closurerelative to the second end of the second belt member. The front closuresmay define first and second clamping sections arranged to removablysecure to opposed sides of the foldable portions of the belt members.

The second ends of the first and second belt members may each includefasteners extending from an outer side of the spinal orthosis forsecuring to a surface of the first and second belt members on the outerside of the spinal orthosis. For example, an entirety or substantialentirety (such as areas with the exception of the fasteners orventilation features) of the belt members may be formed from hookreceivable material. At least one surface of the belt members, sucheither an outer surface or an inner surface opposite the outer surfaceand intended to be adjacent and face the body of the user, may definehook receivable material. The fasteners may be hook material that canengage along the length between the fasteners and the rear panel of thebelt members themselves to allow for significant sizing of the beltmembers beyond predetermined settings of a small group of selections, asin the prior art.

The belt members are preferably of low profile in height and thickness.For example, the first and second belt members have a thickness in therange of 1 to 5 mm, and more preferably in the range of 1.5 to 2.5 mm.The belt members may be devoid of padding or spacer material, as in theprior art, and rather rely on both surfaces being formed byhook-receivable material with a substantially thin thickness, identifiedas being within the range noted above. The belt members may includeventilation features defined by the belt members themselves, such thatthe belt members are continuously constructed from the same materialbetween the first and second ends. The ventilation features may includeperforations of a defined shape and size, and may include a regionthereabout having a reduced thickness from the remainder of thethickness of the belt members. The belt members may include reducedthickness regions without the perforations, to facilitate bending of thebelt members and contribute to overall comfort and compliance of thebelt members to the user.

The rear panel preferably includes a closure system having at least onetensioning element with a handle. The at least one tensioning elementextends from the closure system and the handle is removably securable toa first surface of the first front closure. A rigid posterior platehaving a connector may removably secure to an inner side of the rearpanel to relieve pressure over spinous processes while applying an evenpressure to paraspinal musculature to ensure comfortable and effectivehealing. Similarly, a rigid anterior plate may be secured to the innerside of the belt members at the anterior side of the spinal orthosis.These rigid plates may be added or removed depending on the motionrestriction and compression desired during a rehabilitation period.

In an embodiment, the rear panel includes a stretchable cover extendingfrom the first and second sides. The cover is arranged for stretching orretracting over a variable distance according to adjustment of theclosure system. The first and second belt members may be formed from asubstantially non-stretchable material such that pulling the second endsof the first and second belt members causes the variable distance toincrease, and releasing the second ends causes the cover to retract to apredetermined distance.

The rear panel includes a closure system and a first end of an elongatetensioning element engages the closure system, and a handle secures to asecond end of the tensioning element. The first belt member forms achannel including a first opening proximate the closure system and asecond opening. The channel is formed between first and second surfacesof the first belt member such that the tensioning element enters thechannel at the first opening and exits by the second opening such thatthe second end of the tensioning element extends beyond the secondopening.

The spinal orthosis may be provided as a kit including a rear panelhaving first and second sides, a first belt member having a first endsecured to a first side of the rear panel and a resizable second end,and a second belt member having a first end secured to a second side ofthe rear panel and a resizable second end. A sizing device has first andsecond positioning elements for establishing a clearance defined by apredetermined distance between the second ends of the first and secondbelt members. The predetermined distance allows for same front closuresto be used generally regardless of the length of a user's waist, suchthat the front closures do not require any trimming.

In an embodiment, the first and second positioning elements are firstand second rods spaced apart by a cord having a length extending thepredetermined distance between the first and second rods. In anotherembodiment, the sizing device is a board having a main portion and thefirst and second positioning elements extend from the main portion. Thefirst and second positioning elements are spaced apart by a centersection with a width forming the predetermined distance. First andsecond grooves are formed by the board and separate the first and secondpositioning elements, respectively, from the center section. The kit mayinclude first and second belt expanders arranged for securing to thesecond end of the first and second belt members. The first and secondbelt expanders have first and second ends each bearing fasteners forsecuring to the first and second belt members.

A method for resizing a spinal orthosis comprises the steps of using asizing device having first and second positioning elements forestablishing a predetermined distance between the second ends of thefirst and second belt members. The method includes extending a portionof the second end of the first belt member over the first positioningelement to determine a resized length of the first belt member betweenthe rear panel and the first positioning element. The second end of thefirst belt member is secured over a peripheral surface of the first beltmember to retain the resized length of the first belt member and form afoldable portion of the first belt member. The sizing device is removedafter the resized length is established. A first front closure issecured to the foldable portion of the first belt member. A portion ofthe second end of the second belt member is extended over the secondpositioning element to determine a resized length of the second beltmember between the rear panel and the second positioning element.

These and other features, aspects, and advantages of the presentdisclosure will become better understood regarding the followingdescription, appended claims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an outer side of a prior art spinal orthosis.

FIG. 2 shows an inner side of the prior art spinal orthosis of FIG. 1.

FIG. 3 is a perspective view of the prior art spinal orthosis of FIG. 1having a posterior panel and placed on a user.

FIG. 4 is a perspective view of an embodiment of a spinal orthosis.

FIG. 5 is a detail view of a ring of a front panel in the embodiment ofFIG. 4.

FIG. 6 is a detail view of a belt member extending through the ring ofFIG. 5 and securing to itself.

FIG. 7A is a plan view of another embodiment of a spinal orthosis.

FIG. 7B is a plan view of another embodiment of a spinal orthosis.

FIG. 7C is a detail view taken from VIIC in FIG. 7B.

FIG. 7D is a detail view taken from VIID in FIG. 7C.

FIG. 7E is a belt expander for securing to the spinal orthosis of FIG.7A.

FIG. 8 is a perspective plan view of various detachable components inthe spinal orthosis of FIG. 7A.

FIG. 9A is a perspective view of a front closure for use in the spinalorthosis of FIG. 7A.

FIGS. 9B and 9C are plan views showing inner and outer sides of a frontclosure for the spinal orthosis embodiments.

FIG. 9D is a schematic view showing attachment of the front closure inFIGS. 9B and 9C to a spinal orthosis.

FIG. 9E is a schematic detail view showing the front closure in FIGS. 9Band 9C attached to the spinal orthosis.

FIG. 10A is a plan view of a posterior panel for use with the spinalorthosis embodiments.

FIG. 10B is a plan view of a posterior panel of FIG. 10A including acover.

FIG. 10C is a plan view of an anterior panel for use with the spinalorthosis embodiments.

FIG. 10D is a plan view of the anterior panel of FIG. 10C including acover.

FIG. 10E is a plan view of another embodiment of a posterior panel foruse with the spinal orthosis embodiments.

FIG. 10F is a plan view of the posterior panel of FIG. 10E including acover.

FIG. 10G is a plan view of a lateral panel for use with the spinalorthosis embodiments.

FIG. 10H is a plan view of the lateral panel of FIG. 10G including acover.

FIG. 11 is a schematic view of securing front closures to one another inthe spinal orthosis of FIG. 7A.

FIG. 12A is a schematic view of tightening tensioning elements in thespinal orthosis of FIG. 7A.

FIG. 12B is a schematic view of securing the tensioning elements to thefront closures in the spinal orthosis of FIG. 7A.

FIG. 13 is a schematic view showing a method and kit for resizing thespinal orthosis of FIG. 7A by pulling belt members away from a sizingdevice.

FIG. 14 is a schematic view showing the method of FIG. 13 wherein thebelt members are tensioned.

FIG. 15 is a plan view of an embodiment of a sizing device.

FIG. 16 is a schematic view of a user using the sizing device of FIG.15.

FIG. 17 is a plan view of the spinal orthosis of FIG. 7A includingchannels for a tensioning element.

FIG. 18 is a detail view of a first channel in FIG. 17.

FIG. 19 is a detail view of a second channel in FIG. 17.

FIG. 20 is a cross-sectional schematic view of the belt member in FIG.19 including the second channel.

The drawing figures are not drawn to scale, but instead are drawn toprovide a better understanding of the components, and are not intendedto be limiting in scope, but to provide exemplary illustrations.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A better understanding of different embodiments of the disclosure may behad from the following description read with the accompanying drawingsin which like reference characters refer to like elements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are in thedrawings and described below. It should be understood, however, there isno intention to limit the disclosure to the specific embodimentsdisclosed, but on the contrary, the disclosure covers all modifications,alternative constructions, combinations, and equivalents falling withinthe spirit and scope of the disclosure.

It will be understood that, unless a term is expressly defined in thisdisclosure to possess a described meaning, there is no intent to limitthe meaning of such term, either expressly or indirectly, beyond itsplain or ordinary meaning.

FIGS. 4-6 illustrate an embodiment of a spinal orthosis 50 having aposterior panel 52 and first and second belt members 54, 56 extendingtherefrom. An anterior panel 58 includes first and second rings 60, 62having apertures 72 through which the first and second belt members 54,56 extend. The first and second belt member 54, 56 include first andsecond folded parts 64, 66 that extend over the first and second rings60, 62, in which end portions 68, 70 secure to outer surfaces 78 of thefirst and second belt members 54, 56. The first and second rings 60, 62flexibly extend from the anterior panel 58 along a flexible joint 76 topermit adjustment of the first and second belt members 54, 56 relativeto the anatomy of the user. A rigid anterior plate 74 may be secured tothe anterior panel 58.

The spinal orthosis 50 may include a compression or closure system (notshown) proximate the posterior panel as taught in U.S. Pat. No.8,172,779 or U.S. patent application publication 2014/0207041, publishedon Jul. 24, 2014 and incorporated by reference. The spinal orthosis maybe provided without the posterior panel, and only a compression systemat the posterior side such that the spinal orthosis forms a continuouscircumference with the compression system, the first and second beltmembers, and the anterior panel, as generally shown in FIG. 4.

The anterior panel 58 may be flexible, and can be either stretchable ornon-stretchable. In the depicted embodiment, the anterior panel 58 ispreferably non-stretchable so the first and second belt members 54, 56may be tensioned over the first and second rings 60, 62, as they arefolded over the first and second rings 60, 62 and secured to the outersurface 78 of the belt members.

As depicted in FIG. 6, the folded part 64 extends over and along theouter surface 78 of the first belt member 54. This enables quickadjustment for the user as the user only needs to insert the end portion68 under the first ring 60 and secure the end portion 68 onto the outersurface 78 of the first belt member 68. The user can adjust the tensionof the first belt member by removing the end portion and readjusting onthe fly without having to take off the spinal orthosis.

According to the depicted embodiment, the outer surface of the beltmembers includes hook receivable or loop material, and the end portionsof the belt members include hook material engageable with the materialof the outer surface of the belt members. In this variation, the excesslengths of the belt members extending from the rings do not pile up tocreate pressure points along the circumference of the spinal orthosisdirectly adjacent the user.

The spinal orthosis is not limited to securing the end portions 68, 70of the first and second belt members 54, 56, and may be secured along aninner surface of the belt members in a reverse manner to theaforementioned method. The inner surface of the belt members may includehook receivable material, and the end portions are rearrangedaccordingly with hook material. In this variation, the end portions arelocated on the inner side of the spinal orthosis and reduce thepossibility of leaving excess length of the belt members on the exteriorof the spinal orthosis.

FIGS. 7A and 8 show a spinal orthosis 100 including a rear panel 112having first and second sides. A first belt member 114 has a first endsecured to a first side of the rear panel 112 and a second end 123 isconfigured to have a foldable portion 122 adapted to fold over a surface226 of the first belt member 114 to reduce a length of the first beltmember 114. A second belt member 116 has a first end secured to a secondside of the rear panel 112 and a second end 125 configured to have afoldable portion 124 adapted to fold over a surface 226 of the secondbelt member 116.

While the surface 226 in FIGS. 7A and 8 is shown as the outer peripheralsurface of the spinal orthosis, the spinal orthosis may be configured sothe foldable portions 122, 124 go over an inner peripheral surface ofthe spinal orthosis. The outer peripheral surface is the surface definedas being opposite the inner peripheral surface arranged adjacent theanatomy of the user.

The first and second belt members 114, 116 may be removably secured tothe rear panel 112 by first and second flaps 148, 150 extending from thefirst side of rear panel 112, or securable to the first and second beltmembers 114, 116 and the first and second sides of the rear panel 112.Alternatively, the first ends of the first and second belt members 114,116 may be permanently secured to the first and second sides of the rearpanel 112, such as by stitching or other appropriate means.

First and second patches 134, 136 may secure to the foldable portions122, 124 of the first and second belt members 114, 116 and a surface 226of the first and second belt members 114, 116 to maintain an adjustedlength of the first and second belt members 114, 116 obtained byselectively arranging the length of the foldable portions 122, 124.Other methods and structures may be used rather than the patches, suchas snaps or other locking elements selectively located along at leastportions of the length of the belt members. The patches, however, omitthe need for preselecting and limiting the amount of possible lengths asthe length of the belt members is made substantially adjustable and isnot limited to predetermined size settings.

First and second front closures 126, 128 secure over the foldableportions 122, 124 of the first and second belt members 114, 116. Thefirst and second front closures 126, 128 are arranged to connect to thesecond ends 123, 125 of the corresponding belt members 114, 116. Thefront closures 126, 128 form a continuously circumferential loop withthe rear panel 112 and the first and second belt members 114, 116 tocompletely encircle a user's torso and/or other proximate anatomy.

The first front closure 126 includes a locking element 142 defined on asecond side and is arranged to engage a corresponding slot 144, 146defined on a first side by the second front closure 128 for securing thefirst and second belt members 114, 116 to one another. The slot of thesecond front closure 128 defines an opening 144 and a keyhole 146depending at a forward end of the slot proximate the first end of thesecond front closure 128. When the locking element 142 is inserted intothe opening 144, it is directed and slips into the keyhole 146 which issized and configured closely to the size of the locking element 142 tomaintain engagement therewith. The opening 144 is sized greater than thekeyhole 146, and on tensioning of the first and second belt members 114,116 draws the locking element 142 toward the keyhole 146.

The locking element 142 and the slot enables quick and easy locking ofthe first and second front closures 126, 128, as well as quick and easyremoval of the first and second front closures 126, 128 from oneanother. The locking element 142 and slot likewise require consistentdonning and placement of the first and second front closures to oneanother, and require less strength and force for removal as compared toconventional methods such as using hook and loop systems. While thelocking element and slot are preferred, they may be replaced with a hookand loop system with the first front closure including a hook sectionand the second front closure including a corresponding loop section forengagement with the hook section.

The first and second front closures 126, 128 define first and secondpockets 138, 140 along a first side, and are configured and dimensionedfor inserting at least a finger thereinto for locating a second end ofthe first front closure 126 relative to the second end of the secondfront closure 128.

As shown in FIG. 11, the pockets 138, 140 may be arranged to receive ahand of a user so as to remove the necessity of pulling the frontclosures toward one another, and are beneficial for geriatric users thatmay have difficulty pulling ends of the front closures with theirfingers. The pockets ensure consistent placement of the user's hands forlocking the locking element with the slot.

The rear panel 112 includes a compression system (not shown) and astretchable cover 202 extending from the first and second sides. Thecover 202 stretches or retracts over a variable distance D according toadjustment of the compression system. The compression system may bearranged in the same manner as discussed in connection with the spinalorthosis embodiment 50. The first and second belt members 114, 116 areformed from a substantially non-stretchable material such that pullingthe second ends of the first and second belt members 114, 116 causes thevariable distance D to increase, and releasing the second ends 123, 125causes the cover 202 to retract to a predetermined distance D.

First ends of elongate first and second tensioning elements 118, 120engage the compression system, and first and second handles 130, 132secure to second ends of the tensioning elements 118, 120. As shown inFIGS. 12A and 12B, the handles 130, 132 may secure to a surface of thefirst and second belt members 114, 116 and the first and second frontclosures 126, 128 for selective tensioning of the spinal orthosis by thecompression system, as discussed in U.S. Pat. No. 8,172,779 or U.S.patent application publication 2014/0207041.

FIG. 7B exemplifies another spinal orthosis embodiment 101 bearingsimilarity in part to the spinal orthosis 100 of FIG. 7A. In theembodiment of FIG. 7B, the spinal orthosis 101 includes a rear panel 113having first and second sides. A first belt member 115 has a first end241 secured to the rear panel 113 and a second end 242 bearing afastener 243 for securing over a surface 230 of the first belt member.While the surface 230 is preferably an outer surface as compared to aninner surface directly facing and adjacent the user. The fastener 243and the surface 230 preferably form a hook-and-loop fastener attachmentsystem. A second belt member 117 similarly has a first end 244 securedto a second side of the rear panel 113 and a second end 245 with afastener 247. The second belt member 117 has a same surface 230 as thefirst belt member 115, and likewise preferably forms a hook-and-loopfastener attachment system with the fastener 247. The spinal orthosis isenvisioned as being modified so the fasteners 243, 247 can secure to theinner surface of the belt members, with the inner surface having hookreceivable material.

As shown in FIG. 7B, both the fasteners 243, 247 of the second ends 242,245 are located on the same side of the first and second belt members115, 117. Both the first and second belt members 115, 117 are arrangedto be reduced in length and the fasteners 243, 247 secured to the sameside of the spinal orthosis on the surface 230. Such an arrangement isdifferent from known spinal orthoses whereby the second side of a firstbelt member bears hook material, and the second side of a second beltmember bears loop material for receiving hook material of the first beltmember.

The first and second belt arms 115, 117 preferably have a first contour266 tapering from first ends 241, 244 from the rear panel 113 andbecoming linear in a second contour 267 toward the second ends 242, 245.The first contour 266 enables greater coverage over the posterior bodypart (i.e., back) of the user which undergoes compression by the spinalorthosis. As discussed in connection with FIG. 7D, the spinal orthosisincludes a compression system that preferably includes a pulley set. Thefirst contour 266 accommodates the pulley set, whereas the secondcontour provides a more streamlined and narrow belt configuration whereless belt material is required.

Referring to FIGS. 7B and 7D, the spinal orthosis 101 includes first andsecond compression system covers 232, 234 secured to the first ends 241,244 of the first and second belt members 115, 117, and either extendover the rear panel 113, or connect the first and second belt members115, 117 thereto. The compression system covers 232, 234 have contours262, 264 that taper to a center point along the height of the rear paneland flare toward upper and lower peripheral edges of the rear panel. Thearrangement of the compression system covers 232, 234 is provided inpart to maximize stretching of the rear panel 113 at the center point.

The rear panel 113 variably extends the distance between the compressionsystem covers 232, 234, as noted above in connection with the embodimentof FIG. 7A. The rear panel 113 can be made from an elastic material,such as Spandex. The rear panel 113 defines openings 246, 248 throughwhich the tensioning members 118, 120 extend from the compression systemfor selective securement onto the surface 230 of the belt members 115,117, by the first and second handles 130, 132. The openings 246, 248,are preferably reinforced by a tape 254 laminated or welded to thematerial forming the rear panel 113.

The belt members and the compression system covers are preferablyconstructed from a sheet or laminated sheets of loop material. Unlike inmany prior art spinal orthoses, the belt members of the spinal orthosisin FIG. 7B are substantially supple to enable folding of the beltmembers for resizing thereof. For example, the construction of the beltmembers may comprise at least two sheets of loop material formed byknitted fabric laminated to one another without other types ofintermediate materials, such as spacer fabric in the prior art. Thisconstruction results in a substantially thin belt member while havingsome compressibility due in part to the loop material, and with bothinner and outer surfaces of the belt members as having hook-receivablematerial by the loop material structure. Because both the inner andouter surfaces of the belt members is preferably constructed fromhook-receivable material, there is a significant amount of space, suchas along the foldable portions and outside the foldable portions, forsecuring the front closures to the belt members. Unlike the rear panel,the belt members are preferably not elastic, and stretchable.

Referring to FIGS. 7B and 7C, the first and second belt members 115, 117preferably include perforated areas. For example, a first set ofperforations 236 are defined proximate to the first ends 241, 244 of thefirst and second belt members 115, 117. The first set of perforations236 cascade from the first ends 241, 244 and diminish in heightsubstantially according to the taper of the first contour 266 of thebelt members. Additional sets or individual perforations may be formedalong the length of the belt members, such as a second set ofperforations 238 generally located at a mid-length of the belt members,and a third set of perforations 240 generally located near the secondends 242, 245 of the belt members.

Each of the sets of perforations may define a plurality of perforations250 preferably formed through the thickness of the belt members, and aredistinguishable from porosity, weave, and structure of the belt membersin that the perforations have a predetermined shape. The belt membersmay be embossed or have a reduced thickness area 252 about the sets ofperforations. The reduced thickness area 252 is preferably orientedparallel to a height of the belt members, and may extend from one sideor both sides relative to the thickness of the belt members. The reducedthickness area 252 is not limited to being arranged parallel to theheight, but may be arranged in other desirable directions inclusive ofbeing parallel to the length of the belt members. As depicted, thereduced thickness areas 252 preferably have a length shorter than therespective height of the belt members whereat the reduced thicknessareas are located in order to maintain structural integrity of the beltmembers, although the reduced thickness areas may extend the entirety ofthe height of the belt members.

The sets of perforations 250 and the reduced thickness areas 252, eitheralone or in combination, may facilitate bending of the belt members andoffer areas of enhanced breathability without substantially hinderingthe structural integrity of the belt members. As the belt members aresubstantially thin, they may have a thickness of 1 to 5 mm, and morepreferably a thickness of 1.5 to 3.0 mm. The thickness at the reducedthickness areas may have a thickness of 0.5 to 1.5 mm.

FIG. 7D exemplifies the compression system 257 as having first andsecond pulley sets 258, 260. Each of the pulley sets 258, 260 definefirst and second panels 259, 261 which include an array of pulleys 263about which both the first and second tensioning members 118, 120 rotateabout. A first end of the tensioning members is anchored at an anchor265 to one of the first and second panels, and extend through arespective guide 267 likewise formed on the first and second panels.

The first and second panels 259, 261 are considered “single” in thatthey include pulleys 263 for both the first and second tensioningmembers 118, 120, whereby some pulleys are individually dedicated forthe first and second tensioning members. For example, the firsttensioning member 118 is anchored to anchor 267 on the first panel 259,and extends through a first pulley on the second panel, is routed to afirst pulley on the first panel, and back to a second pulley on thesecond panel, and finally then routed to the guide 267 on the firstpanel before extends from the exit hole 246 defined by the rear panel113. The second tensioning member 120 is similarly routed between thefirst and second pulley sets as the first tensioning member 118, but isarranged about different pulleys located below the entirety of thepulleys about which the first tensioning member extends.

From the foregoing, it follows that adjustment of either of the firstand second tensioning members 118, 120 will adjust the first and secondpanels 259, 261 to some degree since all of the pulleys are carried bythe first and second panels. The length of the rear panel 113 andtherefore the distance between the first and second panels 259, 261 willadjust according adjustment of at least one of the first and secondtensioning members 118, 120.

The pulley panels 259, 261 are respectively secured to the first ends241, 244 of the first and second belt members 115, 117 at an edgereinforcement or interface 256, along with ends of the rear panel 113and the compression system covers 232, 234, which serve in part toreinforce the substantially thin and elastic material of the rear panel113. The edge interface 256 may comprise stitching of the aforementionedcomponents together as a unitary interface, or some components may belaminated or welded together or with others stitched to one another.

FIG. 7E depicts a belt extender 268 that is arranged for extending alength of one of the belt members. The belt extender 268 includes afirst end having a fastener 270, such as hook material, and a second endhaving a fastener 272, such as loop material. The second end 272 isshaped to correspond to the second ends 242, 245 of the belt members,and the fasteners 243, 247 disposed thereon for engagement therewith.The first fastener 270 takes the place of the fasteners 243, 247 at thefirst ends of the belt members when the second fastener 272 engages thebelt members. The belt members between the first and second fasteners270, 272 may be formed similarly as the same construction as the beltmembers. The first fastener 270 is preferably located on a differentside of the second fastener 272, although the belt extender may beadapted so the first and second fasteners 270, 272 are on the same side.

Referring to FIG. 9A, an embodiment of the first front closure 126defines first and second clamping sections 160, 162 at a rear section158 arranged to removably secure to opposed sides of the foldableportion 122 of the first belt member 114 in FIG. 8. The first frontclosure 126 includes material 156 at least at the forward end 154 forreceiving the handles in FIG. 8. The material 156 may spread across boththe forward and rear sections 154, 158. The clamping sections 160, 162may be modified over the description in U.S. patent applicationpublication 2014/0081189, published Mar. 20, 2014, incorporated hereinin its entirety, to accommodate foldable portions of a belt memberrather than severed ends of a belt member.

FIGS. 9B and 9C depict another embodiment of a front closure 280defining a first or leading section 282 for securing to a correspondingfront closure on another side of the belt members or a belt member, atrailing section 284 for securing to the belt members, and a thirdsection or divider 286 located between the first and second sections282, 284. A peripheral portion 288 preferably extends about the firstand second sections 282, 284, and is divided by the third section 286.The peripheral binding 288 may define a tapered and/or soft edge.

Both first and second sides 281, 283 of the front closure 280 definepockets 290 delimited by a pocket periphery 292. The first side 281includes a fastener 294, preferably in the form of hook material but mayinclude other know types of fasteners. The second side 283 likewiseincludes a fastener, preferably in the form of hook material formed bythe surface of the front closure 280. The fastener 294 may engage thesurface of the second side 283 or the material surface of the beltmembers.

FIGS. 9D and 9E exemplify how the front closure 280 secures to the beltmembers. The front closure 280 defines a clamp 296 at the second section284, and is preferably defined by first and second flaps 296 a, 296 bbearing hook material that secures onto opposed sides of the beltmember. The flaps 296 a, 296 b preferably extend and open to the thirdsection 286 whereat the flaps 296 a, 296 b hinge from.

The second end 242 of the belt member 115 folds over itself at aselected length at a crease 297 with a first belt member segment 115 aextending between the rear panel (not shown) to the crease 297 and asecond belt member segment 115 b extending from the crease 297 to thesecond end 242. The fastener 243 at the second end 242 secures to thebelt member segment 115 a. The flaps 296 a, 296 b secure to the beltmember 115 at and over the crease 297 by engaging hook surface of thefirst belt member 115.

FIGS. 10A and 10B depict a supplementary panel 164 having a connector172, such as a strap, arranged for removably securing to the compressionsystem covers in the spinal orthosis of FIG. 7B or the belt members 115,117 by fasteners 174 a, 174 b. The connector 172 is preferably elasticso that it can stretch or contract according to displacement of thevariable clearance between the pulley sets and rear panel. The connector172 is slidably retained to the supplementary panel 164 by at least oneslot 170 through which the connector 172 extends. The at least one slot170 enables the connector to stretch outwardly or away from the shell(as shown with the arrows) and contract without detriment to thesupplementary panel.

The supplementary panel 164 preferably includes a plate 166 that may beapertured and is arranged to generally conform in geometry to a lowerback or lumbar region for a user. The plate 164 preferably defines theat least one slot 170. The plate 166 may be substantially rigid orsemi-rigid, or alternatively flexible but upon compression against abody part of a user rendered rigid.

The supplementary panel 164 includes a cover 168 which substantially orfully encases the plate 166. In the embodiment of FIG. 10B, the coverincludes at least one slot 173 generally corresponding in location tothe at least one slot 170 defined by the plate 166. The cover 168defines a slit 177 enabling insertion and extraction of the plate 166from the cover 168. The slit 177 preferably is releasably closeable witha fastener 183 keeping opposed sides of the cover 168 at the slit 177secured to one another. Edge reinforcement 179 is provided about the atleast one slot 173 and additional edge reinforcement 181 may be providedabout the slit 177. The edge reinforcement 179, 181 may be a reinforcingfilm laminated or welded to the material forming the cover 168.

FIGS. 10C and 10D depict an anterior panel 300 arranged for securing tobelt members, particularly near or at the second ends thereof. Theanterior panel 300 includes a substantially rigid shell 302 and aconnector 304 extending through at least one slot 306 formed by theshell 302. The connector 304 is preferably inelastic and has opposedends 308, 310 which secure to one another to form a loop. When securedto one another, the opposed ends 308, 310 bear on an outer surfacethereof a hook material 314 for securing to the first and second beltmembers. The anterior panel 300 may include a cover 312 arrangedsimilarly to the cover for the supplementary panel 164.

FIGS. 10E and 10F illustrate a posterior panel 320 having a rigid shell322 and a connector 324 bearing fasteners 328 similar to thesupplementary panel 164 of FIGS. 10A and 10B for securing to thecompression system covers. The posterior panel 320 likewise includes acover 326 arranged similarly to the cover in the supplementary panel164.

FIGS. 10G and 10H depict a lateral panel 330 having a substantiallyrigid shell 332, and a removable cover 334 bearing a fastener 336. Thelateral panel 330 is arranged for securing to the belt members betweentheir first and second ends for providing lateral side support for thespinal orthosis.

The panels may be used as needed to achieve correct fit and positioning.The rigid posterior panel should be centered on the spine with thebottom of the posterior panel at approximately the sacroiliac joint. Therigid lateral panels should be placed on landing zones on the belt arms,which may be formed by the embossed or reduced thickness regions. Theanterior panel should be centered on the abdomen with the bottom edgejust above the symphysis pubis while still allowing the patient to sitcomfortably.

The panels can be modified as necessary to optimize patient fit andcomfort by removing them from their respective sleeves and adjust thepanels with a heat gun and/or a trimming device. The spinal orthosis isa modular system and can be customized to the needs of the user. Thepanels can be added or removed depending on motion restriction andcompression desired throughout a rehabilitation period. Any of thepanels described herein may include any of the features of the plates orpanels described in U.S. patent application publication 2014/0081189.

FIGS. 13 and 14 depict a kit and method for sizing a lumbar belt havingfeatures of the spinal orthosis 100 of FIG. 7A by adjusting relativelengths of the first and second belt members. A sizing device 175 hasfirst and second positioning elements 176, 178 for establishing aclearance defined by a predetermined distance (A) between the secondends of the first and second belt members 114, 116. The first and secondpositioning elements are first and second rods 176, 178 spaced apart byfirst and second cords 180, 182 each having a length (A) extending thepredetermined distance between the first and second rods 176, 178.

As shown, the second ends of the first and second belt members 114, 116are inserted and pulled over the first and second positioning elements176, 178 to determine a resized length of the first and second beltmembers 114, 116 between the rear panel 112 and the first and secondpositioning elements 176, 178. The patches are used to secure the firstand second foldable portions 184, 186, and pulled and tensioned aboutthe first and second positioning elements 176, 178. The first and secondbelt members 114, 116 are resized to have a new length between the rearpanel and an end of the foldable portions 185, 187.

Of note, the first and second foldable portions 184, 186 bear fastenermaterial, as in the fasteners 243, 247 in the embodiment of FIG. 7B, sofolded portions 185, 187 can extend outwardly (or inwardly) and betensioned about the positioning elements 176, 178 in the same manner,such as extending from inside and over the positioning elements 176,178, as in FIG. 13. By having both the foldable portions 184, 186extending in the same orientation, the user can generally uniformlytension and size the length of the foldable portions 184, 186, as thefirst and second belt members 114, 116 will likewise have the samelength after sizing of the foldable portions 184, 186.

The first and second front closures are secured on the resized first andsecond belt members, and the distance needed to accommodate the firstand second front closures is assured by the length of the cords. Anadvantage to this kit and method is that the first and second beltmembers are sized without a need for trimming. The belt members can beresized according to different needs of a user, and any changes to thebelt members can be redone, reversed and resized without the use ofcomplicated buckles or fasteners.

Turning to FIGS. 15 and 16, another kit and method is provided forresizing the relative belt lengths of the first and second belt membersfor a user. In this kit, the sizing device 188 is a rigid board having amain portion 190 and the first and second positioning elements 192, 194extend from the main portion 190. The first and second positioningelements 192, 194 are spaced apart by a center section 196 with a widthor predetermined distance (A) forming the predetermined distancediscussed above in connection with the sizing device 175. First andsecond grooves 198, 200 are formed by the board 188, and separate thefirst and second positioning elements 192, 194, respectively, from thecenter section 196. Each of the first and second grooves 198, 200include upper grooves 199, 201 arranged to pinch the belt members tobetter retain them relative to the sizing device 188.

In the method shown in FIG. 16, sizing the lumbar belt using the sizingdevice 188 includes placing the first and second belt members 114, 116through the grooves 198, 200, and drawing the foldable portions 122, 124back toward the rear panel so they are tensioned against the first andsecond positioning elements 192, 194 and secured using various meansdescribed above. The folded portions 185, 187 are positioned apart thewidth (A) from one another for placement of the front closures.

FIGS. 17-20 illustrate how the belt members may have means forconcealing various length segments of the tensioning element. Forexample, the first belt member 114 may form a channel 206 includingfirst and second openings 214, 216 for concealing the tensioning element118, in the form of a cable. The channel 206 is formed between first andsecond peripheral surfaces 204, 224 of the belt member 114.

FIG. 18 depicts a section of the rear panel having a panel material 202surrounding the compression system, as discussed above. The panelmaterial 202 may be preferably stretchable to accommodate activation ofthe closure system. The cable 118 extends from interior of the panelmaterial 202 and exits from aperture 210. The cable 118 spans where thebelt member and panel material 202 join at joint 211, and enters thebelt member at an aperture 212. In this embodiment, the panel materialand the belt are constructed differently, although the rear panel andbelt member at the joint may be constructed to permit the cable toextend across the joint in a concealed manner.

Referring to FIG. 19, the cable 118 has a first portion 118A outside thechannel 206 and proximate the first opening 214. A second portion 118Bextends through the first aperture 214 and within the channel 206. Athird portion 118C extends from the second aperture 216 and outside thechannel 206. For any of the openings, an eyelet 208 may be provided toreinforce the material about the apertures.

Referring to FIG. 20, the belt member 114 may include a core includingfirst and second core layers 218, 220 or a single substrate, and firstand second layers 204, 224 forming the first and second peripheralsurfaces such as outer and inner surfaces of the belt, respectively, andon opposed sides of the core 218, 220. A third layer 226 is secured tothe first layer 204 whereby the channel 206 is located between the thirdlayer 226 and the core layers 218, 220. The third layer 226 generallyonly extends between the first and second openings 214, 216 to reinforcethe first layer and facilitate sliding of the cable.

The core 218, 220, and the first, second and third layers 204, 224, 226are laminated to one another with exception of the third layer 226 tothe core 218, 220 to permit opening of the channel 206. The first layer204 is laminated to the core 218, 220 outside third layer 226. Adhesivelayers 222 may be used to secure the various layers to one anotherthrough lamination.

The channel is advantageous in that it serves as a retainer of thecable, and reduces the amount of cable exposed to be tangled or snaggedon external elements. The channel moves the exit point of the cableforward on the belt members which makes it easier for the user to findand see the cable. Various channels may be provided along the length ofthe belt members or a single, long channel may be formed.

The solution provided above eliminates a need for stitching, and insteadrelies on lamination of the layers. The channel is not limited to thesolution provided above, and may indeed include channels formed bystitching of the layers of the belt members.

While the foregoing embodiments have been described and shown,alternatives and modifications of these embodiments, such as thosesuggested by others may be made to fall within the scope of thedisclosure. While the spinal orthosis has been described in combinationwith a spinal orthosis, it will be understood that the principlesdescribed may be extended to other types of orthopedic and prostheticdevices.

The invention claimed is:
 1. A spinal orthosis, comprising: a rear panelhaving first and second sides; a first belt member having a first endsecured to the first side of the rear panel and a second end having afoldable portion adapted to fold over a first surface of the first beltmember and secure to the first surface to reduce a length of the firstbelt member; a second belt member having a first end secured to thesecond side of the rear panel and a second end having a foldable portionadapted to fold over a first surface of the second belt member andsecure to the first surface to reduce a length of the second beltmember; first and second front closures are securable to the second endsof the first and second belt members, respectively, and arranged forremovably securing to one another to form a continuously circumferentialloop with the rear panel and the first and second belt members; whereinthe first front closure includes a locking element defined on a secondside and arranged to engage a corresponding slot defined on a first sideby the second front closure for securing the first and second beltmembers to one another.
 2. The spinal orthosis of claim 1, wherein thefirst front closure defines a pocket along a first side and configuredand dimensioned for inserting at least a finger thereinto for locating asecond end of the first front closure relative to the second end of thesecond front closure.
 3. The spinal orthosis of claim 1, wherein thefirst front closure defines first and second clamping sections arrangedto removably secure to opposed sides of the foldable portion of thefirst belt member.
 4. The spinal orthosis of claim 1, wherein the rearpanel includes a closure system having at least one tensioning elementwith a handle, the at least one tensioning element extending from theclosure system and the handle is removably securable to a first surfaceof the first front closure.
 5. The spinal orthosis of claim 1, furthercomprising a rigid plate having a connector removably securing to aninner side of the rear panel.
 6. The spinal orthosis of claim 1, whereinthe rear panel includes a closure system and a stretchable coverextending from the first and second sides, the cover stretching orretracting over a variable distance according to adjustment of theclosure system.
 7. The spinal orthosis of claim 1, wherein the rearpanel includes a cover stretchable over a variable distance definedbetween the first and second sides thereof, the first and second beltmembers formed from a substantially non-stretchable material such thatpulling the second ends of the first and second belt members causes thevariable distance to increase, and releasing the second ends causes thecover to retract to a predetermined distance.
 8. The spinal orthosis ofclaim 1, wherein the rear panel includes a closure system and a firstend of an elongate tensioning element engages the closure system and ahandle secures to a second end of the tensioning element, the first beltmember forming a channel including a first opening proximate the closuresystem and a second opening, the channel being formed between first andsecond surfaces of the first belt member such that the tensioningelement enters the channel at the first opening and exits by the secondopening such that the second end of the tensioning element extendsbeyond the second opening.
 9. The spinal orthosis of claim 1, whereinthe second ends of the first and second belt members each includefasteners extending from an outer side of the spinal orthosis forsecuring to a surface of the first and second belt members on the outerside of the spinal orthosis.
 10. The spinal orthosis of claim 1, whereinthe first and second belt members have a thickness in the range of 1.5to 2.5 mm.
 11. A method for resizing a spinal orthosis including a rearpanel having first and second sides, a first belt member having a firstend secured to the first side of the rear panel and a resizable secondend, and a second belt member having a first end secured to the secondside of the rear panel and a resizable second end, the method comprisingthe steps of: using a sizing device having first and second positioningelements for establishing a predetermined distance between the secondends of the first and second belt members.
 12. The method of claim 11,further comprising: extending a portion of the second end of the firstbelt member over the first positioning element to determine a resizedlength of the first belt member between the rear panel and the firstpositioning element.
 13. The method of claim 12, further comprising:securing the second end of the first belt member over a peripheralsurface of the first belt member to retain the resized length of thefirst belt member and form a foldable portion of the first belt member;removing the sizing device from the first belt member after the resizedlength is established.
 14. The method of claim 13, further comprising:securing a first front closure to the foldable portion of the first beltmember.
 15. The method of claim 12, further comprising: extending aportion of the second end of the second belt member over the secondpositioning element to determine a resized length of the second beltmember between the rear panel and the second positioning element;tensioning both the first and second belt members by pulling the secondends away from the first and second positioning elements and toward therear panel.
 16. A kit for sizing a spinal orthosis including a rearpanel having first and second sides, a first belt member having a firstend secured to the first side of the rear panel and a resizable secondend, and a second belt member having a first end secured to the secondside of the rear panel and a resizable second end, the kit comprising: asizing device having first and second positioning elements forestablishing a clearance defined by a predetermined distance between thesecond ends of the first and second belt members.
 17. The kit of claim16, wherein the first and second positioning elements are first andsecond rods spaced apart by a cord having a length extending thepredetermined distance between the first and second rods.
 18. The kit ofclaim 16, wherein the sizing device is a board having a main portion andthe first and second positioning elements extend from the main portion,the first and second positioning elements are spaced apart by a centersection with a width forming the predetermined distance, first andsecond grooves are formed by the board and separate the first and secondpositioning elements, respectively, from the center section.
 19. The kitof claim 16, further comprising first and second belt expanders arrangedfor securing to the second end of the first and second belt members, thefirst and second belt expanders having first and second ends eachbearing fasteners for securing to the first and second belt members.